A Medical Device Daily
Prescient Medical (Doylestown, Pennsylvania) reported that it has received European CE mark approval to commercialize its vProtect luminal shield stent system. The device is now approved for use in improving coronary artery luminal diameter in patients with symptomatic ischemic heart disease. The company said the device has the potential to change the way interventional cardiologists treat arterial plaques.
It is designed specifically for softer plaques.
"This CE mark approval represents a significant milestone for the company and reflects the positive results of our clinical studies to date," said Patricia Scheller, CEO of Prescient. "It also marks the beginning of an exciting broad-based clinical program to assess the performance of the vProtect luminal shield in more specific patient groups," she added.
ProFibrix closes on $11M Series B investment
ProFibrix (Leiden, the Netherlands) a developer of products for hemostasis and regenerative medicine, reported the successful closing of a $11 million Series B investment. The financing round was led by new investor Gilde Healthcare Partners, a European life sciences investor, who joins existing investor Index Ventures. Dirk Kersten from Gilde will join the company's supervisory board.
"The proceeds of the financing will be applied to the ongoing clinical development of our lead product Fibrocaps, and to the preclinical development of our pipeline products," said Jaap Koopman, PhD, CEO.
Fibrocaps is based on a mixture of two essential blood clotting proteins, fibrinogen and thrombin, and is a unique dry powder topical tissue sealant that rapidly stops bleeding after or during surgery. Fibrocaps has major advantages over existing liquid tissue sealants: it is ready for immediate use, is stable at room temperature, highly effective and fast acting. Fibrocaps is currently in a Phase II clinical trial in the Netherlands with results expected end of 2009.
ProFibrix expects to submit an Investigational New Drug Application (IND) for Fibrocaps to the FDA in the first half of 2010, and to conduct a combined phase II/III pivotal study in various surgical indications.
Evalve treats 1st patients at Swedish hospital
Evalve (Menlo Park, California), a development of devices for the percutaneous repair of cardiac valves, reported the treatment of the first group of patients with the MitraClip system at the Karolinska University Hospital Solna (Stockholm, Sweden).
The company said that the MitraClip system is the only medical device commercially available in the European Union which provides a non-surgical mitral valve repair option for patients suffering from the effects of functional and degenerative mitral regurgitation (MR).
MR is the most common type of heart valve insufficiency in Europe and the U.S., affecting millions of people worldwide. Significant MR affects more than eight million people in the U.S. and Europe. There are more than 600,000 new diagnoses of significant MR each year in Europe and the U.S.; however, only 20% of these patients undergo surgery each year. Many higher risk surgical patients and non-surgical patients continue to be affected by the chronic volume overload caused by MR, which requires the heart to work harder, and may ultimately lead to heart failure.
The first patients in Sweden were successfully treated by a team led by cardio-thoracic surgeon Anders Jonsson, MD, PhD, assisted by interventional cardiologist Magnus Settergren, MD, PhD, Echocardiography was performed by cardiac anesthetist Jan Hultman, MD, PhD, and clinical cardiologist Reidar Winter, MD, PhD.
"The MitraClip technology has added a new dimension to the treatment of mitral regurgitation. In my initial experience with our first three patients, I was very pleased to see the good result achieved with a single clip in each of our patients. Any less invasive approach for heart valve procedures is worthwhile to consider, especially if the long term results are compatible with the techniques requiring an open thorax. I am looking forward to treat more patients to further evaluate this approach," said Hultman, who is the director of the Clinic in Cardiothoracic Surgery and Anesthesia. "It is very satisfactory for us as a unit to be able to offer this technology to some of our patients. The MitraClip is a device that hopefully will enable us to design the optimal treatment for all different types of patients with MR including high risk and inoperable candidates," added Jonsson who led the team.
Evalve initiated commercial sales of the MitraClip system in Europe under the CE Mark in late 2008.
The MitraClip device is currently being implanted in six Western European countries, including Germany, Italy, the UK, the Netherlands, Switzerland and now Sweden.